510(k) K984444

INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 by Sandhill Scientific, Inc. — Product Code FFX

K984444 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000". The FDA issued a decision of Substantially Equivalent on January 11, 1999. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.